Brain Injury Assessment Study at Hennepin County Medical Center

NCT02706574 | Unknown

• 1 other identifier: HSR 15-4079
• Study Type: observational
• Target: 774
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goals of this study are to develop an objective, multi-modal classification scheme and outcome measures for traumatic brain injury based on several measures: (1) blood-based biomarkers (indicates which cell types are damaged), (2) eye tracking (detects mass effect/elevated intracranial pressure and pathway disruption), (3) radiographic measures of CT and MRI (detect structural abnormalities), and (4) standardized outcome assessments.

Conditions

Traumatic Brain Injury

Keywords

Eye Tracking; Blood-based Biomarkers; CSF-based Biomarkers; Magnetic Resonance Imaging; Computed Tomography Scan; Outcome Measures

Outcome Measures

Primary Outcomes (4)

• Change in Metrics of Eye Movements during Recovery as Measured by Eye Tracking

  Patients will watch a video for 220 seconds as it moves clockwise around the perimeter of a monitor at about 10 seconds per side, resulting in 5 complete rotations of 40 seconds each. As the patient watches the video, their eye movements will be recorded by a camera.

  Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year.

• Change in Proteomic Concentrations of Blood-Based Biomarkers during Recovery as Measured by Blood Draws

  Blood will be drawn for proteomic analysis at each follow-up time point. Blood will also be drawn acutely for genomic analysis.

  Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year.

• Change in Observable Neural Abnormalities as measured by Magnetic Resonance Imaging

  A group of patients will be selected based on presenting symptoms to undergo a MRI within a week of their injury and again 1 year after their injury. The sequences for these scans will include T2 Flair, susceptibility weighted imaging, diffusion weighted imaging, and diffusion tensor imaging.

  Post-Injury Time Points of Data Collection: within 1 week and at 1 year.

• Computed Tomography Scan

  A group of patients that had an acute CT scan at admission will be selected based on presenting symptoms to undergo a CT scan at 1 year post-injury.

  Post-Injury Time Point of Data Collection: 1 year.

Secondary Outcomes (7)

• Change in Neurological Examination during Recovery as Measured by the Neurological Outcome Scale after Traumatic Brain Injury

  Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year.

• Change in Cognitive Function and Symptom Severity during Recovery as Measured with the Sports Concussion Assessment Tool 3 (SCAT3)

  Post-Injury Time Points of Data Collection: 2 weeks, 4 weeks, 3 months, 6 months, and 1 year.

• Change in Quality of Life during Recovery as Measured with the Mayo-Portland Adaptability Inventory-4 (MPAI-4)

  Post-Injury Time Points of Data Collection: 3 months, and 1 year.

• Change in Global Outcome during Recovery as Measured with the Glasgow Outcome Scale-Extended (GOS-E)

  Post-Injury Time Points of Data Collection: 3 months, 6 months, and 1 year.

• Change in Memory Performance during Recovery as Measured with the Galveston Orientation and Amnesia Test (GOAT)

  Post-Injury Time Points of Data Collection: 3 months and 1 year.

Study Arms (4)

Isolated Traumatic Brain Injury

This group will present to our Level 1 Trauma Center with a Traumatic Brain Injury and no other associated injuries. They will be older than age 4, have no major neurologic or psychiatric disorder, be developmentally normal, and will not be prisoners.

Isolated Body Trauma

This group will present to our Level 1 Trauma Center as a trauma patient with no injury to their head. They will be older than age 4, have no major neurologic or psychiatric disorder, be developmentally normal, and will not be prisoners.

Combined Traumatic Brain Injury and Body Trauma

This group will present to our Level 1 Trauma Center as a trauma patient that had injuries to both their head and body. They will be older than age 4, have no major neurologic or psychiatric disorder, be developmentally normal, and will not be prisoners.

Healthy, Uninjured Controls

This group will consist of subjects that have not been exposed to any major trauma in the previous 12 months. They will be older than age 4, have no major neurologic or psychiatric disorder, be developmentally normal, and will not be prisoners.

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will include all trauma patients that present to the HCMC Emergency Department, trauma bay or as a direct transfer to neurosurgery.

You may qualify if:

• All trauma patients that present to Hennepin County Medical Center.

You may not qualify if:

• Age \> 4 years old;
• Major psychiatric or neurologic disorder: Active Psychotic Break, Trauma due to Suicide Attempt, Epilepsy, Multiple Sclerosis, Dementia, Guillain Barre Syndrome/Chronic Inflammatory Demyelinating Polyneuropathy, Significant Neurodegenerative Disorders, Muscular Dystrophy, and/or Malignant Intracranial Mass with Significant Mass Effect.
• Developmentally Abnormal, or
• Prisoners.

Sponsors & Collaborators

• CentraCare: lead
• Abbott Diagnostics Division: collaborator

Related Publications (3)

• Samadani U. A new tool for monitoring brain function: eye tracking goes beyond assessing attention to measuring central nervous system physiology. Neural Regen Res. 2015 Aug;10(8):1231-3. doi: 10.4103/1673-5374.162752. No abstract available.

  PMID: 26487847 BACKGROUND

• Samadani U, Ritlop R, Reyes M, Nehrbass E, Li M, Lamm E, Schneider J, Shimunov D, Sava M, Kolecki R, Burris P, Altomare L, Mehmood T, Smith T, Huang JH, McStay C, Todd SR, Qian M, Kondziolka D, Wall S, Huang P. Eye tracking detects disconjugate eye movements associated with structural traumatic brain injury and concussion. J Neurotrauma. 2015 Apr 15;32(8):548-56. doi: 10.1089/neu.2014.3687. Epub 2015 Feb 6.

  PMID: 25582436 BACKGROUND

• Samadani U, Farooq S, Ritlop R, Warren F, Reyes M, Lamm E, Alex A, Nehrbass E, Kolecki R, Jureller M, Schneider J, Chen A, Shi C, Mendhiratta N, Huang JH, Qian M, Kwak R, Mikheev A, Rusinek H, George A, Fergus R, Kondziolka D, Huang PP, Smith RT. Detection of third and sixth cranial nerve palsies with a novel method for eye tracking while watching a short film clip. J Neurosurg. 2015 Mar;122(3):707-20. doi: 10.3171/2014.10.JNS14762. Epub 2014 Dec 12.

  PMID: 25495739 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood draws will be taken for both proteomic and genetic analysis at acute and follow-up time points. The specimens will be used to test a specific set of biomarkers related to traumatic brain injury, and they will also be retained for future discovery efforts of novel biomarkers.

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Uzma Samadani, MD, PhD

  Physician, Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 11, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2022
• Last Updated: February 4, 2021

Record last verified: 2021-02